Accelerate European Market Access With Compliant And Comprehensive MAA Submission

Obtaining approval to place a medicinal product in the European market requires a license, a process overseen by the European Medicines Agency (EMA). Meeting EMA's requirements for a Marketing Authorization Application (MAA) involves numerous complex tasks, including building a Pharmacovigilance System Master File (PSMF), developing a Risk Management Plan (RMP), and registering for EudraVigilance. Additionally, assigning an EU Qualified Person for Pharmacovigilance (QPPV) and a Local Person responsible for Pharmacovigilance (LPPV) in certain countries is legally required.

Lacking in-house expertise and experience to navigate these requirements can lead to costly delays in achieving a successful submission of your MAA. ProPharma's extensive knowledge and network in EU QPPV and LPPV, coupled with our deep understanding of the MAA process, streamline this complex process, saving you valuable time and effort.